Trials最新文献

{"title":"Continuous versus intermittent lumbar CSF drainage in aneurysmal arachnoid hemorrhage: a prospective, randomized controlled trial protocol.","authors":"Kuangyang Yu, Wen Tan, Lu Jiang, Jinwei Pang, Fengwang Xue, Kunyang Bao, Changren Huang, Yong Jiang, Jianhua Peng","doi":"10.1186/s13063-026-09887-x","DOIUrl":"10.1186/s13063-026-09887-x","url":null,"abstract":"<p><strong>Background: </strong>Hydrocephalus, as a common complication following aneurysmal subarachnoid hemorrhage (aSAH), not only leads to neurological dysfunction in patients but is also associated with a relatively high mortality rate.</p><p><strong>Methods: </strong>This study is a prospective, single-center, randomized controlled trial. It is planned to recruit 256 patients with aSAH (parallel design, with a 1:1 allocation). Subjects will be assigned to the continuous lumbar drainage (LD) group and the intermittent LD group after undergoing surgical treatment (within 72 h). The primary outcome events will be defined as the degree of improvement in patients' 180 (± 7 days) modified Rankin Scale (mRS) and Glasgow Outcome Scale (GOS) scores, incidence of shunt-dependent hydrocephalus, and 30 days mortality after randomization. Recruitment will be finished by November 2027. All the patients will be followed for at least 180 (± 7 days). The trial is scheduled to complete in 2028.</p><p><strong>Discussion: </strong>This study aims to explore the safety and effectiveness of different LD methods after aSAH, evaluate whether there are different impacts on the neurological prognosis of patients, and determine whether the incidence of shunt-dependent hydrocephalus varies among different methods. It is intended to provide high-quality evidence-based medical evidence for the clinical management of hydrocephalus after aSAH.</p><p><strong>Trial registration: </strong>ChiCTR2500096647 with chictr.org.cn. Registered on 27 January 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13632333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148413005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the effect of a long inspiratory ramp time during pressure-controlled ventilation with volume guarantee: study protocol for a randomized, controlled trial.","authors":"Johannes Hell, Jonas Manke, Stefan Schumann","doi":"10.1186/s13063-026-09888-w","DOIUrl":"10.1186/s13063-026-09888-w","url":null,"abstract":"<p><strong>Background: </strong>The inspiration of pressure-controlled ventilation is characterized by an initial sharp increase of flow rate. The resulting peak flow rate could induce a disproportionately high mechanical load, transferred from the ventilator to the pulmonary structures. A higher inspiratory ramp time could decrease the peak inspiratory flow rate, which might reduce the mechanical power transmitted to the lungs. This study compares pressure-controlled ventilation with volume guarantee with low and high inspiratory ramp time and the effects on the mechanical load transferred from the ventilator to the patient's lungs.</p><p><strong>Methods: </strong>This is a randomized, controlled single-center trial, in which patients receive pressure-controlled ventilation with volume guarantee with short (clinical standard) or increased inspiratory ramp time. Mechanical power will be compared between the two types of ventilation. Further, the effects of the respective ventilation setting will be evaluated with the Horowitz index, the mean airway pressure, and changes in respiratory system compliance. The occurrence of atelectasis will be investigated utilizing electrical impedance tomography. Additionally, lung-specific proteins in patients' blood will be measured, seeking indications of mechanical stress in their dynamics and postoperative pulmonary complications will be recorded and compared between groups.</p><p><strong>Discussion: </strong>This trial aims to evaluate the feasibility of decreasing inspiratory flow rate during pressure-controlled ventilation with volume guarantee by increasing inspiratory ramp time and to analyze its effects on mechanical power, oxygenation, respiratory system mechanics, atelectasis, and postoperative pulmonary complications. Furthermore, lung-specific proteins in patients' blood will be examined in regard to find a novel, helpful biomarker, representing the mechanical load of the lungs. The results of this study could provide valuable information to improve perioperative mechanical ventilation with a reduced mechanical power through a simple an ubiquitously available modification of the breathing pattern, namely increasing inspiratory ramp time. Additionally, identification of a lung-specific biomarker reflecting mechanical load of the lungs might enhance research of lung-protective ventilation.</p><p><strong>Trial registration: </strong>German Clinical Trials Register (DRKS), DRKS00035496. Registered on 12 November 2024; URL: https://drks.de/search/en/trial/DRKS00035496/details . Local Trials Register: Freiburger Register of Clinical Studies (FRKS), FRKS005304.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13339386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148405950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of tranexamic acid on early allograft dysfunction following liver transplantation: study design for a prospective randomized controlled trial.","authors":"Yajie Zhang, Xiaozhen Wei, Haibei Liu, Yanhua Qiu, Qi Li","doi":"10.1186/s13063-026-09678-4","DOIUrl":"10.1186/s13063-026-09678-4","url":null,"abstract":"<p><strong>Background: </strong>Hemorrhage and coagulation management are critical during liver transplantation (LT). Hyperfibrinolysis is a major contributor to perioperative blood loss. Tranexamic acid (TA), an antifibrinolytic agent, has been reported to reduce transfusion requirements during LT. Several studies have demonstrated that intraoperative transfusion is independently associated with early graft dysfunction (EAD), which may prolong recovery, increase sepsis incidence, and elevate mortality. However, clinical evidence regarding the prophylactic administration of TA for reducing EAD in LT remains limited. This study aims to test the hypothesis that prophylactic TA use during LT can reduce the incidence of EAD.</p><p><strong>Methods: </strong>This is a prospective, single-center, randomized, parallel-group study. Two hundred sixty-eight adult participants scheduled for liver transplantation under general anesthesia will be included in this study. In the TA group, participants will receive a continuous infusion of TA (10 mg/kg/h) from anesthesia induction until portal vein unclamping. In the placebo group, an equivalent volume of 0.9% saline will be administered in the same manner. Anesthesia protocol will be identical in both groups and conducted according to routine clinical practice.</p><p><strong>Discussion: </strong>To our knowledge, this is the first prospective randomized controlled trial to investigate whether prophylactic use of TA is effective in reducing EAD incidence for LT recipients.</p><p><strong>Trial registration: </strong>This trial is registered at www.chictr.org.cn (ChiCTR2300079022). Registered on 23 December 2023.  https://www.chictr.org.cn/showproj.html?proj=215007 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13621644/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148397703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"SWAT 116: the effectiveness of an infographic to improve trial recruitment-a randomised study within a trial (SWAT).","authors":"C E Arundel, F Wiggins, K Baird, C Fairhurst, A Mott, S Swan, J Wilkinson, S Zahra, I Chetter","doi":"10.1186/s13063-026-09830-0","DOIUrl":"10.1186/s13063-026-09830-0","url":null,"abstract":"<p><strong>Background: </strong>Randomised controlled trial recruitment is challenging. Recruitment and informed consent processes require provision of a participant information sheet (PIS). Visual presentation of information, in the form of an infographic, is increasingly utilised, despite limited effectiveness evidence. This Study Within A Trial (SWAT) assessed if a PIS plus an infographic increases recruitment relative to PIS alone.</p><p><strong>Methods: </strong>A two-arm cluster randomised SWAT (1:1 allocation ratio at the site level), embedded within the SWHSI-2 trial. The primary outcome was recruitment rate analysed via mixed effects logistic regression using minimisation factors as fixed effects and site as a random effect. Secondary outcomes were the proportion of participants screened but not recruited, retention rate, and cost.</p><p><strong>Results: </strong>All 29 SWHSI-2 sites were randomised to the SWAT (14 intervention; 15 control). Following SWAT implementation, 1634 patients were screened, with 1068 patients eligible (PIS plus infographic, 662/1008 [65.7%]; PIS only, 406/626 [64.9%]) and 585 randomised into the SWHSI-2 trial (PIS plus infographic, 342/662 [51.7%]; PIS only, 243/406 [59.9%]; (OR 0.61, 95% CI 0.23 to 1.62, p = 0.32). More patients were screened but not randomised in the intervention group compared to the control group (n = 666, 66.1% vs n = 383, 61.2%). Meta-analysis of two studies found the infographic intervention reduced participant recruitment (OR = 0.61, 95% CI 0.31 to 1.23).</p><p><strong>Conclusion: </strong>Two SWAT replications have found that including an infographic alongside a PIS does not increase participant recruitment, but estimates were imprecise. Replications in other populations and exploration of infographic content and design remain warranted.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13621630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148397862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nurse counselors' experiences of recruitment and retention of female sex workers in a HIV vaccine trial: a qualitative study from urban Tanzania.","authors":"Masunga K Iseselo, Edith A M Tarimo, Joel S Ambikile, Gift G Lukumay, Patricia Munseri, Mohamed Bakari, Eligius Lyamuya, Said Aboud","doi":"10.1186/s13063-026-09835-9","DOIUrl":"10.1186/s13063-026-09835-9","url":null,"abstract":"<p><strong>Background: </strong>Nurse counselors play a pivotal role in recruiting and facilitating the retention of volunteers in HIV vaccine trials. They act as the primary interface between the research team and volunteers, typically tasked with educating, supporting, and guiding participants through the trial process, including adherence to the study protocol for care and safety. There is limited research on the series of experiences and challenges faced by nurse counselors during the recruitment and retention of volunteers in HIV vaccine trials. This study aimed to describe the experiences of nurse counselors in recruiting and retaining female sex workers in the HIV PrEP and Vaccine (PrEPVacc) trial.</p><p><strong>Methods: </strong>This employed a descriptive qualitative study design nested within the larger phase IIb three-arm, two-stage HIV prophylactic vaccine trial conducted in Dar es Salaam, Tanzania. The qualitative data were collected among three nurse counselors and one field worker who participated in 16 debrief sessions. The participants were purposefully selected due to their roles and responsibilities in the recruitment and retention of volunteers. The audio-recorded sessions were transcribed verbatim, and the content analysis approach was applied.</p><p><strong>Findings: </strong>The study revealed that nurse counselors felt responsible and honored through enhancing volunteers' recruitment and enrollment, ensuring retention, and facilitating trial interventions. The availability of a supportive trial environment, engagement meetings, collaboration among staff and volunteers, good staff performance, and volunteers' positive attitude were the qualities for effective management of volunteers in the trial. However, the participants described encountering barriers to trial recruitment and retention, such as volunteers' noncompliance with trial requirements, perceived lack of honesty, personal life and family resistance, stigma, and social perception.</p><p><strong>Conclusion: </strong>The nurse counselors can encounter great turmoil while ensuring recruitment and retention in an HIV vaccine trial. Despite the challenges, volunteer engagement and adherence to study protocol are important for maintaining the continuity of trial procedures over time. Collaboration among staff and engagement of volunteers are essential to enhancing retention until the end of the study.</p><p><strong>Trial registration: </strong>The trial was registered with the US clinicaltrials.gov on 29 September 2021 and can be found at https://clinicaltrials.gov/study/NCT04066881 .</p><p><strong>Registration number: </strong>NCT04066881.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13617680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148397816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TaILOR: a randomised trial to compare the clinical and cost-effectiveness of a patient-initiated follow-up (PIFU) strategy compared to standard care pathways in people with inflammatory arthritis: a study protocol.","authors":"Gretchen Brewer, Victoria Harris, Christopher Mwema, Abhishek Abhishek, Ailsa Bosworth, Christine Bundy, Clare Clark, Elizabeth Conroy, Helen Dakin, Emma Dures, Joe Eddison, Anne Francis, James Galloway, Alice Jennings, Helen Lall, Elizabeth MacPhie, Sam Norton, Mark Perry, Jane Raleigh, Mel Brooke Turfrey, Laura Coates","doi":"10.1186/s13063-026-09868-0","DOIUrl":"10.1186/s13063-026-09868-0","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory arthritis comprises lifelong conditions, such as rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis that require long-term treatment and regular monitoring. People with inflammatory arthritis usually require long-term treatment with immune-suppressing medications and are typically reviewed in outpatient clinics every 6-12 months, accounting for 1.3 million appointments/year in the UK. The National Health Service (NHS) is implementing a move to patient-initiated follow-up (PIFU) where patients request appointments as required. To date, there are small studies of PIFU in rheumatoid arthritis and none in other arthritis. Research is required to configure services to optimise outcomes, inform patients and clinicians of the effectiveness and safety of PIFU and ensure that suitable patients are selected for this pathway.</p><p><strong>Methods: </strong>TaILOR is a two-arm, pragmatic, parallel group, superiority, randomised controlled clinical study, with an embedded qualitative study conducted across 32 secondary care NHS sites in the UK. Eligible participants must be 18 years or older, with stable inflammatory arthritis, and diagnosed for at least 2 years. In addition, they need to be suitable for PIFU based on NHS England guidance and in the opinion of their usual care team; 438 participants will be randomised in a 1:1 ratio to either PIFU, with a fixed 24-month safety net appointment, or standard care, with 6-12 monthly follow-up visits. The trial includes an internal recruitment feasibility pilot, as well as health economics and qualitative analyses. The primary outcome will assess the effectiveness of PIFU compared to standard care on musculoskeletal quality of life at 24 months. Secondary outcomes include quality of life, incremental costs, cost-effectiveness, treatment escalation, disease activity, flares, patient confidence in interactions with their clinical team (patient perceived efficacy in patient-physician interactions), depression and acceptability of PIFU (via qualitative interviews).</p><p><strong>Discussion: </strong>As a national multi-centre study, this will provide the definitive evaluation of PIFU for inflammatory arthritis. Qualitative analysis will generate insights into individual and contextual factors affecting the acceptability of PIFU, identify variation across sites or between patients and provide information on how this can be addressed.</p><p><strong>Trial registration: </strong>ISRCTN ISRCN10480648. Registered on 17 January 2025. Protocol version {2}: Version 3.0 date 04 Dec 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13343589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Scaling up community-based non-communicable disease research into practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial.","authors":"Yoko Inagaki, Sweta Koirala, Maryam Hameed Khan, Kamal Ghimire, Pabitra Babu Soti, Niraj Bhattarai, Pratibha Bhandari, Chathurangi H Pathiravasan, Buna Bhandari, Rajshree Thapa, Khim Bahadur Khadka, Zhengbang Yao, Archana Shrestha, Vanessa Garcia-Larsen, Eric A Finkelstein, Justin B Moore, Svea Closser, Lawrence J Appel, Per Kallestrup, Dinesh Neupane","doi":"10.1186/s13063-026-09842-w","DOIUrl":"10.1186/s13063-026-09842-w","url":null,"abstract":"<p><strong>Background: </strong>Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials have documented that task-sharing with community health workers (CHWs) can reduce systolic blood pressure (SBP), reduce fasting blood glucose, and achieve smoking cessation. However, most studies have been conducted in rural settings or focused on managing a single condition, such as hypertension only.</p><p><strong>Methods: </strong>We propose an open-label, two-armed, community-based cluster-randomized controlled trial in Pokhara Metropolitan City of Nepal, the second largest city in Nepal. A total of 30 clusters will be randomized into intervention or control arm in a 1:1 ratio. An individual is eligible if living in Pokhara Metropolitan City and having one or more of the following conditions: hypertension, type 2 diabetes, and tobacco smoking. The participants will be recruited through study team home visits. The intervention group will receive an intervention package \"SCALE-NCD\" which includes (1) home-based monitoring, referral, and counseling for self-management of hypertension, diabetes, and tobacco smoking by Female Community Health Volunteers (FCHVs), and (2) weekly mobile phone messages to promote healthy lifestyle. FCHVs are CHWs in Nepal whose usual tasks are limited to maternal and child health care services. The control group will receive usual care, where there is neither of aforementioned two components. Primary outcomes are change in SBP, change in fasting plasma glucose, and change in smoking cessation, the required sample size for which is 405, 105, and 525 per arm, respectively.</p><p><strong>Discussion: </strong>This study will inform us of the effectiveness of FCHV-led home-based management of the top three NCD risk factors coupled with weekly mobile phone messages in urban Nepal. Building on the previous studies that measured the efficacy of FCHV-led home-based management of a single NCD risk factor in a small geographical area, this scaled-up study will provide us with the realistic impact that FCHVs may have if they are trained to provide primary care services for management of major NCD risk factors.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06740708. Registered on 2024-12-13.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13599303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment of genitourinary syndrome of menopause with fractional CO₂ laser versus fractional microablative radiofrequency: study protocol for a double-blind, randomised, non-inferiority trial.","authors":"Cássia Caroline Garcia Dalbem Teles, Catarina Maria Mesquita Garcia Dalbem, Matheus Rodrigues de Souza, Nivaldo Antonio Parizotto","doi":"10.1186/s13063-026-09865-3","DOIUrl":"10.1186/s13063-026-09865-3","url":null,"abstract":"<p><strong>Background: </strong>Genitourinary syndrome of menopause (GSM) affects a significant proportion of postmenopausal women, leading to symptoms such as vaginal dryness, irritation, dyspareunia, and urinary symptoms. Hormonal therapies are not suitable for all patients, particularly those with contraindications to hormone use. This study aims to compare the efficacy and safety of two non-hormonal therapies-fractional CO₂ laser (CO₂ laser) and fractional microablative radiofrequency (MAFRF)-for the treatment of GSM.</p><p><strong>Methods: </strong>This protocol describes a randomised, double-blind, non-inferiority clinical trial that will enrol 40 postmenopausal women diagnosed with GSM. Participants will be randomised to receive either fractional CO₂ laser or fractional microablative radiofrequency in three monthly sessions. The primary outcome will be the Vaginal Health Index Score (VHIS), assessed 30 days after the last treatment session (day 90). Secondary outcomes include sexual function, GSM symptom severity, and urinary symptoms. Follow-up assessments will be conducted at 120 and 300 days after the last session (days 180 and 365, respectively). Histological analysis of vaginal biopsies will be performed in a predefined subsample of participants as an exploratory analysis.</p><p><strong>Discussion: </strong>This study is expected to contribute to the comparative understanding of the efficacy and safety of CO₂ laser and MAFRF as non-hormonal therapeutic options for the treatment of GSM, potentially supporting clinical decision-making for women who are not candidates for hormonal therapy.</p><p><strong>Trial registration: </strong>Brazilian Clinical Trials Registry (ReBEC): RBR-2hgwvgy. The trial was registered retrospectively due to administrative delays in the registration process. However, no outcome data were accessed, analysed, or used to inform any decisions prior to registration, and no interim analyses were performed. Additionally, no modifications were made to the study design, outcomes, or planned analyses after the initiation of data collection. Registered on July 2, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13617837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of early tracheostomy in infratentorial lesions trial: rationale and design.","authors":"Song Han, Meng-Ya Li, Yuan-Chao Cheng, Chang-Xiang Yan","doi":"10.1186/s13063-024-08682-w","DOIUrl":"10.1186/s13063-024-08682-w","url":null,"abstract":"<p><strong>Background: </strong>Tracheostomy is a common procedure in patients who undergo surgical resection of infratentorial lesions. However, the optimal timing and high-risk factors for tracheostomy remain unknown.</p><p><strong>Methods: </strong>Value of Early versus Standard Tracheostomy in patients with Infratentorial Lesions (VENTIL) is a prospective, randomized, controlled, open-blinded endpoint (PROBE design) trial. Patients who have undergone resection of infratentorial lesions will be recruited within 48 h postoperatively based on a prediction score. This study will include 152 patients. Patients will be randomized 1:1 to either the early tracheostomy (< 2 days after surgery) or the control group (≥ 2 days after surgery). The primary endpoint is the occurrence of pneumonia by day 14 after resection of infratentorial lesions. The secondary endpoints include the modified Rankin scale score at 6 months, mortality, length of intensive care unit and hospital stays, time to successful extubation, and adverse events.</p><p><strong>Conclusion: </strong>High-risk factors and optimal timing for tracheostomy in patients undergoing resection of infratentorial lesions need to be identified. Therefore, VENTIL should clarify the clinical benefits of early tracheostomy in these patients.</p><p><strong>Trial registration: </strong>This trial is registered on February 5, 2024, at chictr.org.cn (ChiCTR2400080714).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13673802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EECP intervention and coronary flow reserve in chronic coronary syndrome: a protocol of a multicentre, randomised controlled study in China (ECP-Core Trial).","authors":"Yanlong Leng, Yuan Li, Xue Jia, Shuai Tian, Yundan Jiang, Ling Lin, Yinfen Wang, Wei Pan, Jianwen Liang, Fensheng Wu, Wenjuan Zhou, Zhijuan Liao, Xinxia Zhang, Guifu Wu","doi":"10.1186/s13063-026-09878-y","DOIUrl":"10.1186/s13063-026-09878-y","url":null,"abstract":"<p><strong>Background: </strong>Few non-invasive approaches are available for improving coronary function in intermediate-risk chronic coronary syndrome (CCS) patients. Over the past 30 years, enhanced external counterpulsation (EECP) has been widely accepted and recommended for treating CCS in clinical guidelines. However, the effect of EECP on coronary function remains to be quantitatively validated in intermediate-risk CCS patients. Fractional flow reserve (FFR) is a gold standard (quantitative index) of coronary artery function, and FFR < 0.80 is regarded as an indicator for percutaneous coronary intervention (PCI) in clinical decision-making. However, FFR is invasive and cannot be performed repeatedly within a short time interval; therefore, FFR is not suitable for large-scale verification of the effect before and after EECP treatment. Conversely, with advancements in numerical theory and computation hardware, FFR derived from coronary computed tomography angiography (FFR_CT) performs similarly to FFR used in coronary artery function measurement. Additionally, FFR_CT is non-invasive and highly acceptable to patients. Therefore, in this study, we aim to explore whether EECP therapy can improve FFR_CT in patients with intermediate-risk CCS and further enhance the long-term prognosis of CCS.</p><p><strong>Methods: </strong>This prospective, multicentre, randomised controlled trial is blinded to the examination executors and analysts. One hundred four participants will be recruited, and they will be divided into the EECP and control groups. The primary outcome of this study is the between-group difference in FFR_CT changes from baseline to follow-up. The secondary outcomes refer to between-group differences in ΔFFR_CT, wall shear stress, axial plaque stress, total exercise time, time to 1 mm ST-segment depression, Seattle Angina Questionnaire score, and cardiovascular-related composite endpoint events.</p><p><strong>Discussion: </strong>This is the first study to use the non-invasive coronary artery function index, FFR_CT, to evaluate the efficacy of EECP in patients with CCS. It comprehensively evaluates the treatment efficacy from multiple dimensions, including exercise capacity, symptom changes, and prognosis. Therefore, this will potentially provide reliable evidence to inform treatment strategies for CCS.</p><p><strong>Trial registration: </strong>Trial registration number: ChiCTR2400079915. Registered on January 16, 2024 (retrospectively registered), https://www.chictr.org.cn/about.html .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602779/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}